R&D Information Sheet Adverse Events: R&D responsibilities v

Transcription

1 R&D Information Sheet Adverse Events: R&D responsibilities v FLOWCHART A ACTIONS OF R&E ON RECEIPT OF AN SAE/SUSAR REPORT Record on safety database for annual reports Is SUHT the sponsor/cosponsor? Remind PI to inform Sponsor Is the investigator performing the assessment unblinded? Is the SAE either a SUSAR or a non-imp SUSAR Go to FLOWCHART B A SUSAR is an SAE that has occurred in a clinical trail of an IMP and is possibly, probably or definitely related to the IMP and unexpected. A non-imp SUSAR is an SAE that has occurred in a trial of a device or intervention that is not an IMP and is, possibly, probably or definitely resulted from administration of any of the research procedures, and is unexpected.

2 FLOWCHART B ASSESSMENT OF SAES IN BLINDED STUDIES Can a member of the research team perform an unblinded assessment without compromising the study? Request unblinded assessment within 5 days Identify a suitably qualified & experienced person to perform unblinded assessment Is the SAE assessed as either a SUSAR or a non- IMP SUSAR? Request unblinded assessment within 5 days Is the SAE assessed as either a SUSAR or a non- IMP SUSAR?

3 FLOWCHART C DETERMINING WHETHER THE SAE IS A SUSAR OR NON-IMP SUSAR Is the study and IMP study? The event is a SUSAR Go to FLOWCHART D The event is a non-imp SUSAR Report to Main REC within 15 days Inform CI and PI of action taken. Where the CI/PI are blinded do not provide information that would break the blinding.

4 FLOWCHART D ACTION REQUIRED FOR LIFE THREATENING AND NON-LIFE THREATENING SUSARS Is the SUSAR assessed as fatal or life threatening? Report to MHRA and Main REC within 7 days Report to MHRA and Main REC within 15 days Report any additional information within 8 days of initial event

5 FLOWCHART E - ACTION REQUIRED IN SPECIAL CASES Is the SAE any of the following? a. single case reports of an expected serious adverse reaction with an unexpected outcome (e.g. death); b. an increase in the rate of occurrence of an expected serious adverse reaction, which is judged to be clinically important; c. post-study SUSARs that occur after the patient has completed a trial; d. a new event, related to the conduct of the trial or the development of the investigational medicinal product (IMP), that is likely to affect the safety of subjects, such as: a serious adverse event which could be associated with the trial procedures and which could modify the conduct of the trial; a significant hazard to the subject population such as lack of efficacy of an IMP used for the treatment of a life-threatening disease; further action required. Is event fatal or life-threatening?. Report to MREC* within 7 days Report to MREC* within 15 days Send any additional information within eight days of sending the first report. Continue to send information until event resolved. Send any additional information within eight days of sending the first report. Continue to send information until event resolved. More detailed information and forms for assessment and reporting of SAEs can be found in the SUHT Research Related Adverse Event reporting Policy available on the R&D office website.